Evaluation of Ketamine and Multi-modal Analgesics

Pain Clinical Trial

Official title:

Evaluation of Ketamine and Multi-modal Analgesics for Postoperative Analgesia, Opioid Sparing, and Early Extubation in ICU Compared With Conventional Analgesia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02815111
• Other study ID #: IRB201600316
• Status: Withdrawn
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: July 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research study is to see if pain can be better controlled with fewer side effects. The new drug regimen will study several different medicines that have different ways of treating pain.

Description:

The investigators plan to study an analgesic regimen of Ketamine and Lidocaine as infusions with Neurontin and acetaminophen delivered orally for postoperative analgesia and the subsequent effect on ventilator days and ICU stay. The investigators expect that pain scores will be either unchanged or better than historic controls. In addition, the investigators expect that ventilator days and ICU stay will be improved due to reduced incidence of delirium and bowel dysfunction.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) status 1-4

• Undergoing planned surgery for cardiac problems

• 18 years of age and not older than 85 years of age

Exclusion Criteria:

• Severe liver disease (alanine aminotransferase (ALT) , aspartate aminotransferase (AST), or bilirubin > 2.5 times Upper Limit of Normal)

• Pregnancy or currently breastfeeding

• History of schizophrenia or other hallucinatory psychiatric disorder

• History of chronic or pre-existing pain disorder

• History of heart block

• Severe renal impairment Creatinine Clearance (CrCl)<30 milliliter(mL)/min

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ketamine
Receive an analgesic regimen that involves Ketamine infusions
• Lidocaine
Receive an analgesic regimen that involves Lidocaine infusions
• Acetaminophen
May be administered Acetaminophen rectally, by mouth, or intravenously in patients not suitable for either of the other methods of administration
• Neurontin
May be given Neurontin by mouth as an approved medication for pain control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes between the two groups assessed by overall ventilator days	Total ventilator days	Through study completion, an average of one week
Secondary	Changes between the two groups assessed by ICU length of stay	ICU length of stay	Through study completion, an average of one week